Furthermore, the addition of a €5.1B EU-financial boost to accelerate digital innovation, and interoperability adoption makes Europe the new Digital Health Mecca for 2021 and beyond. However, with so much funding, innovation, and encouraging policies, the responsibility is also to prove positive socio-economic impact and health outcomes.
Pit-Stop
As DTx is still taking baby steps to higher maturity and adoption levels, it's a good time for a pit-stop to reassess the broader DTx context and redefine their strategic value proposition.
The reality of clinical practice, and that of patients, is often made of intricate complexities which cannot be addressed by – let alone resolved through – a single or even an array of standalone DTx interventions. Indeed, patients with musculoskeletal (MSK), cardiovascular, metabolic, and other conditions often take painkillers and/or other disease-specific drugs. Moreover, because care delivery is still very often based on physicality, professional health services still are a cornerstone of any care plan today.
In this context, although the benefits of some of the DTx interventions dealing with their specific conditions have been backed by clinical evidence, their share of the benefits and the degree to which they interact with drug intake and other health professional's interventions are still poorly documented.
The DTx Golden Triad
These three types of interdependent health interventions – Digital, Pharmacological and Physical – represent what we call the DTx Golden Triad (DGT). Physical interventions embed a sub-category of actions, including but not limited to physiotherapy, Cognitive Behavioural Therapy (CBT), and diets.
Because of this interdependence, future clinical and cost-effectiveness research (CCER) studies on DTx will have to more actively assess the extent of these interventional interactions and the degree to which they could be beneficial to the patient for a given medical condition.
Examples from the market
Because of the intertwined roles medical interventions play in managing every patient's condition, it is necessary to shed new light on DTx. So far, only very few DTx have managed to integrate the intervention triad seamlessly and successfully. One very advanced such DTx application is already changing the lives of asthma patients. It is a true digitally enhanced intervention that uses the power of Internet-of-Things (IoT) to embed inhaler sensors data with environmental information, representing a more holistic context of the asthma patient. In doing so, this DTx objectively measures the patient's adherence to therapy (inhaler) while recording their outcomes and the environmental conditions around them. Just as the idea of preventing an asthma patient from allergen exposure is as beneficial as an inhaler puff, the combination of both becomes a powerful strategy in the right context. Future integration of real-time oxygen saturation levels and other parameters will help manage even better asthma outcomes.
Conversely, other DTx applications, like some used in MSK interventions, integrate professional health services with digital triage and activity coaches. Still, there's no embedded documentation on the use of painkillers or other drugs over time that the patient is under the DTx intervention. Whatever evidence might be backing these MSK DTx interventions, the absence of documenting synergistic therapies represents a bias in interpreting the study results. It could therefore alter the validity of the DTx claims. In other words, focusing solely on the benefits of MSK DTx while ignoring the benefits of concomitant pharmacological interventions to reduce pain and reinstate range of motion is just 'half the science' and can therefore not represent the full solution. The DTx approach to MSK conditions is not wrong at this early stage, but from a clinical standpoint, somewhere between incomplete and misleading. It's like studying plant growth in the absence of sunlight.
There's a whole body of scientific evidence underscoring the benefits of non-Western therapies such as both traditional and electromagnetic acupuncture in MSK patients – and not integrating those in related DTx interventions would not serve the best interest of the patient. It is extremely difficult to get everything right from the outset. Still, company strategies grounded in clinical research and scientific evidence (i.e., not restricted to Western medicine) should use those outputs to identify therapeutic biases and redress product development roadmaps accordingly.
Notwithstanding, pharmacological interventions are not always prescribed, and therefore they may or may not be part of the final DTx spectrum. The example of CBT using VR-Goggles to treat acrophobia (fear of heights) through virtual exposure is one of many. However, some phobic patients under a CBT intervention may already be taking anxiolytics. Therefore, the documentation of that drug intervention will help to interpret the digital therapy impact better.
The scientific argument behind the DTx Golden Triad
During my years in residence in the early '90s, our Rheumatology Department at Hospital Mongi Slim in the suburbs of Tunis had a collaboration with a Chinese University Hospital that resulted in setting up two practice sections for our outpatient clinic: one for Western and one for Traditional Chinese Medicine (TCM). The two practices shared a pool of patients. Five years in, the experiment suggested that over 30% of patients who did not respond to classic Western interventions saw their MSK impairments significantly reduced through an enhancement by TCM interventions. Meanwhile, the effectiveness of acupuncture (both verum and sham methods) documented in the 2007 German Acupuncture Trials (GERAD) in 1162 patients with chronic low back pain (LBP) was almost twice that of conventional therapy six months after the trial.
Also, the prescription of adjunctive therapeutic interventions is a well-established practice with documented benefits. Indeed, when indicated, the reinforcement of core muscles for LBP patients goes further than a stand-alone prescription of painkillers. And although the latter is generally used for their short-term benefits, they also help lower the point of discomfort (PoD) under which the patient would be able to run her mobilization exercises. In layman's terms: health professionals always know another set of interventions and the benefits of their associations, either by personal experience within their field of expertise and/or through scientific evidence. In a survey 28% of German doctors cited 'lack of trust' and 'lack of info' on DTx as primary reasons for not adopting and prescribing them. Embedding the DGT principle in the development of DTx interventions will help cover a wider array of interventions and lower the barriers to physicians' adoption.
Regulatory adjustments
Understanding the potential – not only the current role DTx is to play in healthcare – should inform the policy frameworks regulating them. And while advanced frameworks like the German DiGA helped spur innovation and adoption in this space, building a DTx maturity-adoption model based on real-world scientific evidence is a shared duty between regulators, DTx companies, VC funds, health providers, and payers. However, as regulators are 'neutral patient advocates with a muscle,' their role in re-framing DTx strategies around the DGT should not be underestimated.
Recommendations
Because of the variance in response to clinical interventions and the degree to which they interact, the future of DTx lies within its capacity to identify and enhance the best combination of effective therapeutic interventions for the patient. In the case of MSK conditions, unlocking that DTx capacity will be a critical differentiator between 'a digital physiotherapy session with strong health warnings' and a true digitally enhanced health intervention based on sound and complete evidence.
For next-generation, more effective DTx interventions, we recommend companies engaging in the design and development of such products to:
- Engage a multidisciplinary team with a more patient-centric approach, including the DTx Golden Triad. The art is doing so while staying lean.
- Use comprehensive intervention effectiveness assessments involving multiple tools and metrics that have been validated for the target condition(s). Remember: 'exclusive interventions' are a metaphor.
- Keep a strong body of governance around the design process and the use of successful practice approaches. Your company's outputs can only be as good as the governance and the people you surround them with.
DTx play an increasingly pivotal role in delivering truly personalized medicine within the context of validated value-based care practices. Their scientific credibility and adoption levels can be further enhanced by effectively integrating the DTx Golden Triad and extending the indication spectrum of the same DTx to a broader array of co-morbidities in the same patient. The nuclear power plant behind these promising DTx platforms will be nothing else but Machine Learning – and there lies a whole new sea of tremendous opportunities and risks to be discussed in our next paper.
The author declares no conflict of interests in the elaboration of this paper.
