Digital therapeutics: how do we bring order from chaos?

THE era of technology is well and truly upon us, and the presence of digital therapeutics in the form of applications for mobile phones and tablets is ubiquitous. So why is there a lag in genuine disruptive change in health care?

A recent article reported that in the past 10 years, since smartphones have become widespread, the estimated number of available mobile health (mHealth) apps has exponentially increased to approximately 325 000, and this is on the rise. These apps range from symptom checkers, self-monitoring, remote monitoring, and adherence and rehabilitation facilitators, to management of clinical and financial records, and health care professional finders.

The potential ability of health apps (known as digital therapeutics) to increase awareness, improve prevention, aid diagnosis and assist in disease management is obvious. Yet, the medical community as a whole, although generally accepting of the use of apps as part of a broader clinical toolkit, are slow in their utilisation or recommendation to patients. Furthermore, a large proportion of the population don’t even download these apps, or when they do, there is a rapid decline in utilisation, with 30-day retention rates of 59% across all prescribed mHealth apps, according to the latest report from the IQVIA Institute for Human Data Sciences. So much so, that there is little evidence that many of them actually make a difference from a health perspective.

How do we leverage technology as a facilitator of clinical care to achieve real impact?

We currently see three major problems in the digital therapeutics space:

1. There is a lack of evidence of efficacy.

Robust data on whether mHealth apps actually work are lacking. As such, they pose novel challenges for patients and clinicians alike, with the availability of infinite choices of unproven products and minimal guidance as to which app to use. In a study by Byambasuren and colleagues, the authors systematically reviewed the literature looking for what they described as “prescribable” mHealth apps, defined as apps that are currently available, proven effective, and preferably stand-alone. The study demonstrated that a very small proportion of apps have been tested to assess their impact. Of those that were tested, only 11 trials showed a clear effect. The authors suggested that more potentially worked, but they had not been tested.

Similarly, Sucala and colleagues carried out a review of apps available on Google Play and the Apple iTunes app store which help consumers cope with anxiety disorders. They found 52 apps available, of which only two (4%) offered information about the efficacy of the data to support the apps.

2. Consumer engagement is not prioritised.

Consumers are the end users of these products. This could be the patient using the application, a physician, or other health care team members. As app development cycles are time-sensitive and have strict development targets, the end users’ expert opinion and feedback on what the app is trying to address and achieve may be neglected. There needs to be a shift in these processes, as we know that consumers are only likely to use an app, and continue to use it, if they feel it addresses their needs, is easy to use and actually works.

3. Cost-effectiveness

As consumers, we all would rather use an app that is free, or one that we only have to pay a small one-off amount for. This is the general consensus across the board with all consumers. Consumers also voice their reluctance to pay an ongoing fee for additional or updated content. The digital landscape is rapidly changing, particularly in health care, resulting in a need to keep content accurate and up to date and interfaces fresh. The lack of consumer desire to spend and the expensive consulting costs required to ensure that apps are functional, repeatedly tested, and updated, and have a design that works, seem to be another barrier in app development. This results in either poorly designed apps with minimal functionality provided for free, or effective, sophisticated apps for which it is challenging to identify a sustainable business model.

Where does this leave us?

We need to ensure that mHealth apps are functional, practical, user-friendly, affordable and tested. This seems like a lot to get right. However, we can achieve all of this by using what is already available to us in order to improve the number of prescribable apps that can truly facilitate improved clinical outcomes.

• App design must be simple but also functional; utilising consumer groups with lived experience in a particular disease area is critical.
• Testing of apps to generate efficacy data using traditional clinical trials approaches just won’t work. They are time-consuming and by the time results are generated, it is too late. The app will have become outdated and redundant. Study design for efficacy trials of digital health apps need to be pragmatic and adaptive and involving real-world conditions.
• We must use routinely collected datasets to generate evidence of effectiveness in the real world and use these data to continually innovate and improve based on consumer feedback and clinical evidence updates.
• We must consider novel business models other than purchase by the consumer or the Department of Health. We should consider businesses or areas of the health system that benefit from interim steps in the clinical pathway who may be willing to subsidise use to generate downstream revenue options.

There is much hype around the potential and prospects of digital therapeutics; however, the true disruptive potential of these technologies has yet to be realised. The full adoption of digital therapeutics is limited by a number of barriers that, unless addressed, may limit their full potential. These barriers are impeded further by a complex health care system with limited interoperability both within and across health care organisations. As new products enter the digital technology market, consumers are in a strong position to ensure apps are effective and functional whether used to treat disease or improve health and wellness.

Dr Shane Galgey is a researcher in the Office of the Chief Scientist, at The George Institute of Global Health. His areas of research interest include digital health, cardiovascular disease prevention and economic burden of disease, with a particular focus on men’s health.

Dr Ruth Webster is Global Head of Medicine in George Health Technologies, a social enterprise of The George Institute for Global Health. As a researcher, she has a particular interest in the development of novel strategies to bridge the evidence–practice gap in cardiovascular disease prevention. She is actively involved in trials of various types of polypill strategies, as well as improving the use of technology in general practice.

The statements or opinions expressed in this article reflect the views of the authors and do not represent the official policy of the AMA, the MJA or InSight+ unless so stated.