Anxiety, depression), diabetes, hypertension, but also the fight against addictions or physical rehabilitation. These are some of the areas in which it is possible to use DTx which include digital applications, artificial intelligence and algorithms that are real drugs. It is a sub-category of digital health tools (which include software or hardware components) but unlike the latter they are therapies based on scientific evidence obtained through controlled and randomized clinical trials, as is the case for measuring the effectiveness of traditional drug therapies. To better understand what these are and what exactly their scope is, Frontiere interviewed Eugene Santorohead of the Medical Informatics Laboratory of the Public Health Department of the Mario Negri Institute of Pharmacological Research as well as Curator of the “Digital Health” item of the Treccani Encyclopedia.
What exactly are DTXs and how are they classified from a regulatory point of view?
“Digital therapies, also known as digital therapeutics or DTx, are technologies that offer therapeutic interventions guided by high quality software programs, based on scientific evidence obtained through methodologically rigorous and confirmatory clinical trials, to prevent, manage or treat a broad spectrum of physical, mental and behavioral conditions. The treatment of digital therapies is based on changes in behavior or lifestyles and / or on the (digital) application of cognitive-behavioral interventions through the implementation of guidelines and programs. from a regulatory point of view, they are included among medical devices (currently regulated by the Medical Devices Regulation of 2017 – MDR 2017/745 – which came into force in May 2021), although some characteristics differentiate them from these “.
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Can we consider them as real curative interventions?
Certainly, because they are capable of acting on clinical outcomes by improving them, like a drug treatment. They are based on different digital tools. Our recent scientific review conducted on clinical trials concerning digital therapies on ClinicalTrials.gov (the most important international clinical trial registry) and presented at the recent congress of the European Society of Cardiology, showed that the digital tools used to develop them are based on smartphone applications (42%), on traditional web-based systems (26%), on videogames (9%) and on virtual reality (4%).
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In which areas of pathology are they already used?
Especially for those pathologies or medical areas in which therapies based on cognitive behavioral theory and on the modification of lifestyles are already applied and used in traditional forms. They are therefore used for the management of diseases related to mental health (such as anxiety and depression), for the prevention and management of chronic diseases (such as diabetes and hypertension), for the fight against addictions (including smoking), to improve sleep quality, to promote rehabilitation and physical movement. This is also demonstrated by one of our studies which identified the percentages of use of digital therapies in the first four categories indicated above at 35%, 19%, 13%, and 9% respectively.
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Are clinical studies also conducted to evaluate the efficacy of DTx?
“We begin to better clarify the concept of clinical study. With this term, when we talk about digital therapies, we mean the randomized controlled clinical study, typically used to study the efficacy of drugs. In summary, we compare the results obtained later. to the technological intervention in those who used it compared to those obtained by those who, on the other hand, used the standard treatment. To avoid possible conditioning effects, the technological treatment is assigned randomly, thus identifying two homogeneous groups that differ only from the use (or not) of the intervention under study. In short, the most solid, from a methodological point of view, exists to guarantee the safety and efficacy of the solution under study “.
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Let’s take a concrete example: last year the FDA approved EndeavorRx as a digital therapy, the first video game for children aged 8 to 12 with ADHD (attention deficit disorder). Has a clinical study been conducted on this therapy?
“This technology has been evaluated on more than 600 children through five different randomized clinical trials (the data of which have been published in the leading scientific journals in the sector) which highlighted the effective ability of digital therapy to reduce (in this category of patients) attention deficit. Another recent example is the approval, also in the United States, of a digital therapy that uses a virtual reality headset to modify the content of TV shows and films to help children with amblyopia, or the eye. lazy, improve visual acuity. “
What are the advantages in terms of effectiveness of the result and in terms of any economic savings?
“Clinical studies involving digital therapies measure the advantage in terms of clinical results. Reduction of anxiety / depression states, glycated hemoglobin (an important measure for diabetes sufferers), blood pressure values, number of cigarettes smoked (or of people who resume smoking after quitting) are some of the clinical benefits demonstrated by digital therapies. These improvements can also be related to economic savings. For example, on drug use (since in many cases these therapies are alternatives to traditional ones based on drugs), on the number of admitted hospitals or in the emergency room, on the number of health services, on the need to travel to reach medical facilities “.
And what are the disadvantages instead?
“The digital divide is the most important problem, especially if digital therapies are aimed at an elderly audience. Furthermore, we must not forget that, as with drugs, there may be side effects associated with the prolonged use of digital therapies. for example, the study that validated EndevorRx showed that there are side effects, such as migraine, typical of those who use digital tools too much, especially those that use video and involve sight “.
Are there any concrete examples of Dtx already available in Italy and actually used?
“In Italy, unfortunately, things do not proceed as in the rest of the world (such as the USA, Great Britain, Germany and Japan), where digital therapies have been a reality for some years now. Here, for example, digital therapies are available. such as ReSET (an app that offers cognitive-behavioral therapy to treat those suffering from addiction and opioid abuse problems), BlueStar Diabetes (a diabetic patient management app), online programs such as those from Omada Health to help lose weight by decreasing heart risk, SleepIo to improve sleep quality, Kalmeda to treat tinnitus through personalized cognitive-behavioral therapy, Velibra for anxiety management “.
How much do doctors and patients know about this?
“Unfortunately, digital therapies are still little known by doctors and patients. And when they claim to know them they fail to place them in the large area of digital medicine and digital health, often confusing them with tools for which no scientific validation exists and with those belonging to the category of gadgets. A great work of training doctors, health workers and patients would help to clarify and understand / make the most of the potential they offer. In this regard, the Mario Negri Institute of Pharmacological Research, which has been attentive to training doctors and patients, has been offering training courses on digital health, digital medicine and digital therapies since 2018, independently or in collaboration with other institutions and partners “.