Could digital health applications improve the health of COPD patients?

COPD is a disease for which there is no cure with the majority of cases resulting from cigarette smoking or environmental exposures [1]. COPD patients have symptoms nearly every day although the symptom burden is quite variable among patients. Pulmonary function and symptoms worsen over time, and are often punctuated by episodes of acute deterioration (exacerbations) that may last from several days to weeks. Exacerbations can be treated in an outpatient setting, in the emergency department, or in the hospital depending on their severity. Exacerbations that require care in the emergency room or hospitalization are associated with greater morbidity and mortality compared to those treated as an outpatient [2]. Therapeutic interventions that can improve the health of patients with COPD include smoking cessation, various pharmacological interventions for both daily maintenance therapy and treatment of exacerbations, pulmonary rehabilitation, routine vaccinations, and oxygen therapy [1,3]. In addition to these interventions, COPD patients can also benefit through increased symptom awareness (also called self-actualization) to promote early recognition of worsening symptoms and the timely institution of rescue therapy [4]. Each of these interventions offers a potential avenue for digital health applications to improve the health of COPD patients. Despite this, it is rare to find a COPD patient using any kind of digital application to assist in the management of their condition, which begs the question, ‘Why? ’ Not all mobile medical applications are equal. The distinctions are discussed in an US FDA guidance issued in February 2015 that identifies two major categories of mobile medical applications [5]. The first category includes those mobile applications that the FDA intends to regulate. Examples of this category include: (1) applications that connect to an FDA-regulated medical device to control the device or one that provides active patient monitoring or analyzes patient-specific medical data; (2) applications that use attachments that make a mobile platform function in the same way as a regulated medical device; and (3) mobile applications that collect and analyze data to provide a patient-specific diagnosis or treatment recommendation. An example of this type of mobile application is the Propeller Sensor Model 2014-R (Reciprocal Labs, Corp. Madison, WI). The device has a 510 (k) approval and is available by prescription only. This application uses Bluetooth technology and a sensor that attaches to the patient’s inhaler to record and monitor inhaler use. The device records inhaler use and this information can be stored for review at a later time by the patient, caregiver, or health-care practitioner, or transmitted. Because these types of devices are designed for patient diagnostic or management purposes a more stringent FDA review process is required. Similarly, the information obtained is intended to be reviewed and analyzed by a health-care provider to make medical decisions. Decisions made on the basis of this information would be subject to the same medical-legal concerns as with any other test or procedure results. The second category of mobile applications consists of those that provide general guidance or information to a patient on how to manage their disease without making specific treatment recommendations, help organize the patient’s medical record, or assist in communicating with health-care providers. The FDA does not intend to regulate these applications; however, it may regulate these devices in what is termed ‘enforcement discretion. ’ Most of the mobile medical applications that are easily downloadable fall into this category because, by definition, they are considered to present a minimal risk to the user. The FDA guidance provides a number of examples of mobile medical applications from this second category that could prove useful in the management of COPD. COPD patients might find applications that help them to stop smoking, stick with pulmonary rehabilitation exercises, and remind them to take prescribed medications quite useful. Applications that utilize global positioning system location information to help the patient identify known areas where environmental conditions may worsen their symptoms might also have a place for selected patients. While the mobile applications described in this second category are easily accessible, little information exists as to how useful they are in achieving the desired outcome. This leaves patients and physicians in a quandary as to which app to select for use and assumes that the patient and physician can agree on the behavior that needs to be supported [6]. Should the patient receive assistance for smoking cessation, or is medication adherence more important? Should symptoms be recorded to be downloaded and discussed at a later time, or should they EXPERT REVIEW OF RESPIRATORY MEDICINE, 2016 VOL. 10, NO. 4, 377–378 http://dx.doi. org/10.1586/17476348.2016. 1157476