During the 1980s, Barcelona found itself at the centre of a mysterious asthma epidemic. No less than 26 separate outbreaks of the lung condition, which causes sudden breathing difficulties, occurred over a six-year period, affecting several thousand people and resulting in more than 10 deaths.
It would take a global team of researchers to finally identify the culprit – dust being released into the air from soya beans being unloaded from ships in the city’s port.
Fast forward to 2010, and this story would inspire the creation of a new digital therapeutics company called Propeller Health, which aims to use the power of AI to better monitor people suffering from respiratory problems, as well as how effectively their condition was managed by their medication. To do this, Propeller uses a new generation of inhalers – called smart inhalers – which are equipped with sensors that connect to a smartphone app.
Guy Checketts, head of transformation and evaluation at Health Innovation Oxford & Thames Valley, explains how the data collected from a smart inhaler can be used for treatment: “That data goes to the clinician, allowing them to build up an electronic record. Is the patient complying with their medication and dosage or are they not using it at all? And if they are being compliant and aren’t being effectively treated, should the healthcare provider consider alternative approaches?”
This is just one example of a particular class of digital therapeutics that is used to support a pharmaceutical treatment, aiding and monitoring use. Checketts notes that other companies are developing a range of similar digital therapeutics to support patients with conditions ranging from chronic obstructive pulmonary disease to diabetes and heart disease.
Digital therapeutics are a new generation of web and app-based health tech that can be used to monitor the effectiveness of a drug or to actually deliver treatments such as cognitive behavioural therapy (CBT). It’s an exciting emerging field that is markedly different from the plethora of health and wellness apps out there. Before they can make it to market, digital therapeutics face a breadth of challenges, from the myriad complexities of designing such a tool to rigorous testing and ensuring compliance with strict data storage and privacy regulations.
Creating user-friendly platforms
Katie Holmes, NHS Talking Therapies lead at Birmingham and Solihull mental health NHS foundation trust vividly recalls the first attempts to develop digital therapeutics – and their distinct limitations. “This was 12 years ago, and there would be a website where you had to log in and use a portal,” she says. “The graphics looked awful, and they were very clunky and not particularly user friendly. But now they’re able to keep you engaged in a way that wasn’t possible before.”
She says that it is key for developers to deliver information in simple and slick ways that are interactive. “If you’re trying to over-explain stuff or there’s too much on there, people get bored,” she says. “There’s definitely some which are overcomplicated – you have to market it at a relatively low reading age to make sure it’s accessible for everybody.”
But designers don’t just have to account for readability and ensuring their tool is easy to navigate. For such a digital therapeutic to be considered by the NHS, it needs to be inclusive for a breadth of users, reflecting the diversity of the UK population, and available in multiple languages.
Many digital therapeutics involve the user receiving a therapy such as CBT through a cartoon-like virtual avatar, so it is important for them to be able to customise the avatar’s appearance, for example, so it shares their skin tone. Holmes says that it is particularly important for users to be able to relate to any characters present within the therapeutic, in the wake of various studies that have shown that the success of real-life psychological therapy is influenced by the bond between patient and therapist. “In real life, we work really hard to make sure our workforce represents a population, so that if someone has a preference to see somebody who looks like them, or is from the same culture, that’s a possibility,” she says.
Meeting the highest standards
However, the biggest challenge for any digital therapeutic is to demonstrate efficacy, typically through studies and even clinical trials, the method used to assess new medicines. But running a robust trial involves comparing one patient group who are using the therapeutic with another who are using a placebo.
Replicating this process for digital therapeutics is something of a headache for developers, with one study detailing some of the placebos considered – such as digital applications that contain general wellness content or games. “It’s not as straightforward as with drug trials where you can give one group a sugar pill,” says Matt Williams, senior programme manager for mental health at Health Innovation Oxford & Thames Valley. “You can’t easily do that with digital.”
Developers also need to be able to convince NHS providers that they have evidence that their therapeutic works, not only in the relatively restricted environment of a clinical trial, but among the general population. Holmes explains: “You can pay a lot of money to do your own trial, but trying to get it into a real-world environment, such as an NHS talking therapy service for a study is quite difficult, because service managers are busy and don’t want to put extra onus on their clinicians to try something new that might not work.”
While health and wellness apps are typically free and funded by in-app advertising, digital therapeutics come at a cost to the NHS. As a result, Checketts says that the biggest challenge for developers is to prove that their tool will be so effective and convenient that it ultimately saves the NHS money in some way.
“The underlying goal is that the app needs to release money for the system,” he says. “Either because the patient is not needing to utilise the healthcare system as much as before, either with A&E and GP appointments, or pharmaceuticals that cost money. So the questions are: does it deliver benefits in improved outcomes, does it deliver cost savings and does it offer benefits in terms of capacity? Those are the things which are examined to see whether the NHS should adopt it.”
Data security and confidentiality
In an era of increasing sensitivity about the collection and storage of our personal data, digital therapeutics also have to be compliant with strict regulations such as the Data Protection Act and UK General Data Protection Regulation (GDPR), and be able to allay concerns as to where and how a patient’s data will be stored.
Checketts points out that security is also strengthened because users can only access a therapeutic using a dedicated code provided by their GP. Furthermore, according to Williams, most digital therapeutics only store data which is absolutely necessary.
He suggests that the best way to approach the question of data is to reduce the amount that is gathered. “If a therapeutic doesn’t require a lot of data, you just don’t collect it.”
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