Digital measures and pre-competitive collaborations

Today, the impetus to receive care from a physician is feeling sick. A visit to a clinic once a patient is already experiencing symptoms offers providers a very limited snapshot into their patient’s overall health. On the contrary, if providers and patients were able to measure and then manage health outside of the walls of the clinic - and before their patients became ill - the health care system could see increased benefits from cost savings, time savings, and greater efficiencies.

Digital measures for real-world insights

Digital measures gathered in a patient’s home and known environments offer greater insight into their overall health when compared to a singular, granular visit to a doctor’s office. Health data allows for better decisions about patient care, research, and public health policy. Digital measurements thus convert a snapshot clinic visit into real insights of a patient's lifestyle - offering a more well-rounded perspective of their overall health. This data can be collected using connected products such as smartphones, wearables, implantable, ingestible devices, and sensors, and the technology is continuing to evolve at a rapid pace. Access to this data can provide researchers, industry sponsors, and regulators the information they need to make life-or-death decisions and multibillion-dollar investments that will benefit the health care sector and people’s lives. 

Making the digital case for sleep and other matters

Sleep is one of the most important indicators of health. Sleep disorders have been linked to mental health concerns and significant economic impact. Research shows that we sleep better in familiar environments, yet the gold standard for sleep measurement today is in a lab. 

From the researchers' standpoint, the findings from the labs are surely useful, but not very representative of one's everyday habits. Furthermore, the sleep lab research and evaluation of data is expensive, oftentimes manual, as well as time-consuming, and results can vary between different research groups.

In today’s digital era, digital solutions can help those struggling with sleep to better understand the causes, identify health concerns, and take back their lives. And it's not only for the enthusiasts who want to track their sleep - people's other health conditions may start negatively impacting their sleep, or they can start experiencing sleep disturbances on their own. That’s why DiMe recently kicked off a digital measures project to align on a core measure for sleep. 

And it’s not just sleep. The potential of digital health technologies (DHTs) to support measurement across different aspects of a person’s life is far-reaching. Take atopic dermatitis, which is a common, chronic inflammatory skin disease affecting over 2% of the world’s population. 

Patients with atopic dermatitis often experience a number of symptoms, the most common and disruptive of which is itchy skin, which results in severe nightime scratching. These individuals frequently report choosing clothes, routines, and even career paths that make it easiest to manage and hide their symptoms, resulting in major lifestyle changes due to living with atopic dermatitis. When it comes to scratching at night, it is often overlooked or dismissed, because it's not directly observed or measured. However, itching and scratching do indeed happen at night, often disrupt the sleep of the patients, and may have detrimental effects on their everyday life.

Our research efforts into atopic dermatitis have allowed us to develop a core measure for nocturnal scratch. Using this model, clinicians can define how nocturnal scratch connects to meaningful aspects of health for their patients and determine possible outcomes to measure in order to successfully implement digital measurements of nocturnal scratch. 

Digital data: bringing precision medicine to the forefront of diagnostics

This data can enable us to move care upstream, so that patients don’t turn up sick or, even worse, find themselves in an expensive, potentially permanent medical situation. It is able to establish a baseline for what “healthy” truly is for each patient, so their provider can know well before symptoms arise when medical care is needed, and create a digital phenotype of their health, in possession of the information they need to detect early signals of illness or deteriorating health; empowering physicians to take the right action at the right time for their individual patients and bring precision medicine to the forefront of diagnostics and treatment.  

As an industry, we’re realising the importance of developing and aligning on these measures in a pre-competitive space versus a silo. DiMe's digital endpoint library, for example, includes nearly 400 unique entries for digital endpoints, revealing a hugely duplicative effort. Previous efforts to gather data and develop subsequent digital tools proved that technology is critical, but to succeed, it needs to be developed and deployed at scale. 

A collaborative approach will be key to defining digital measures that matter, which meet multi-stakeholder needs, and can support innovation and care with the broadest impact. By convening a balanced and inclusive group of global multi-stakeholder experts, we can define meaningful aspects of health and build consensus for digital clinical measures. To this end, DiMe has also been conducting similar work in the areas of Alzheimer’s Disease and related dementias and physical activity.

Building a valuable digital measurement product

Until now, there's been plenty of guidance. However, a lack of consensus and alignment for making decisions on and using digital measures has prevented the advancement of medical product development. At DiMe, we’re addressing that barrier by providing pharmaceutical companies with the tools needed to de-risk the selection of this endpoint and arming technology innovators with what they need to build a valuable digital measurement product. 

This is possible through successful collaboration with industry stakeholders around a common goal—improving people’s lives and, more broadly, advancing healthcare. Digital measures provide value for speeding the development of effective new therapies and improving care management. Many digital measures can be omni-therapeutic and have diverse applications. The significant benefit comes from breaking down silos and eliminating duplication and, instead, supporting innovation through collaboration to provide clarity and consensus to address the field’s toughest challenges. 

When industry, regulators, payers, clinicians, and academia work together, digital measures can be used uniformly, producing comparable data, and advancing science - ultimately paving the way for the development of effective treatments and improved care management.

About the authors

Candice Taguibao leads the physical activity project at the Digital Medicine Society. Her background in public health and experiences working in the health tech start-up, clinical care, and academic research spaces have supported her current role in facilitating collaboration among diverse stakeholders to define digital measures for physical activity which are meaningful to patients.

Pip Griffiths is a measurement scientist and a project lead for DiMe. She applies the understanding of how to create measures that matter to patients to the development of digital tools. Working with disease specific experts she is able to define measurement strategies that have the potential to change the life of patients.

Lucy Cesnakova, MS, has led a successful flagship project at DiMe that applied frameworks and guidances for digital measurement development to a use-case in a specific therapeutic area - digital measurement of nocturnal scratch in atopic dermatitis. In the past, Lucy has led technical development of digital endpoints or other software solutions as a product lead.