Look behind the lecture: digital medicine transformations in healthcare
In this feature, Ashish Atreja (Mount Sinai Icahn School of Medicine; NY, USA) discusses his presentation from the 3rd Real-World Evidence Forum (15—16 July 2019, PA, USA) on the importance of implementing novel digital technologies in healthcare.
Over the last 5 years, health systems have been increasingly implementing digital health technologies to support value-based transformations. These have created opportunities for physicians and researchers to better engage with populations, know and understand what is happening to patients in real time, provide a good level of education to patients, invigorate and activate patients, and accrue data from patients through electronic patient-reported outcomes.
In this feature, Ashish shares his insights on how such digital transformations have created the space for patient connection with all of digital medicine technology.
Please could you introduce yourself and your institution?
I am an Associate Professor at the Icahn School of Medicine at Mount Sinai (NY, USA). My focus is in gastroenterology and inflammatory bowel disease. I spend approximately 20% of my time working in this physician capacity; however, I spend most of my time in innovation and as the Chief Innovation Officer of Medicine at Mount Sinai. In this latter capacity, I support digital transformations and real-world evidence (RWE) generation across different diseases and disciplines.
How has RWE and healthcare delivery been digitally transformed in recent years?
I think digital transformations, such as the recent advent and increased use of wearables and connected devices, have been complete game changers in the fields of RWE and healthcare. Further, these advancements have, and are, changing the game faster than we ever imagined. I would say that the last 5 years of digital medicine has mostly been concerned with innovation; new technologies have been presented, and experts have been questioning their benefits and whether patients will use and respond well to these. We have been trialing technologies in pilots.
I think the key is to use these new technologies to not only monitor patients and outcomes, but to progress from simple evidence accrual to actionable outcomes for populations.”
Now, however, and I think over the next 5 years, the digital medicine field will be focused on transformations. We will be saying: this is a meaningful technology, how can it be made available to the greatest number of patients to generate evidence from it? I think a great example of this is the recent breakthrough in initial public offering (IPO) by the health startup company Livongo Health (CA, USA). This demonstrates the maturity of technology that is happening; technologies can now generate data that can be fed into, and used to train, artificial intelligence machines to help guide decision making. This has implications across fields ranging from diabetes to hypertension to augmented reality; these technologies and uses are not just theoretical, they are real-world.
How may novel digital technologies allow for improved evidence- and value-based medicine?
I think the key is to use these new technologies to not only monitor patients and outcomes, but to progress from simple evidence accrual to actionable outcomes; to make the transition from real-world data to RWE. At Mount Sinai, we put a lot of effort into working to close this data—evidence loop by making collated data available to those who are going to be acting on that data – statisticians, physicians, researchers – in real-time. This will also help build a platform from which we can engage patients directly, through the use or smartphones, text messages, digital navigation, interactive voice responses or secured messages.
How may we assess the value of/validate digital innovations in RWE and healthcare delivery?
I will answer this by drawing on how, traditionally, cost-effectiveness analyses are done. These are carried out from the perspectives of multiple stakeholders: patients, hospitals, researchers or physicians, and society as a whole. I think it is very important to have such length to the assessment process because sometimes, for example with patient engagement, the value for patient stakeholders may be increased, however, this may not translate to increased value for researchers and healthcare providers. Ideally, we want to create and focus on use-cases that have the potential to create and increase value for all parties in the equation.
…having patients as true partners, not just in research, but also in digital medicine transformation, is one the most effective, and especially cost effective, steps that can be taken.”
Now, with outcomes-based research and value-based contracts – which licensers can arrange with health plans – we can work backwards from the results they yield. We can determine that it is possible to engage patients in real-time, improve their adherence to drug regimes, improve their outcomes, know if we are in fact improving their outcomes, save health systems money and create more opportunities for the life sciences to engage in more contracts with health plans. In this instance: everyone wins.
Using this approach has huge potential to advance the fields of, for example, biologics and cancer immunotherapies, and their accessibility by patients thereafter. These are perfect examples of high-expense areas and high inefficiency fields. In these instances, methods that increase value for all parties are critical for field advancement.
What challenges do we face with applying new digital technologies in real-world settings specifically; why can they fail at this stage when they seemed promising in clinical settings?
I think part of this ‘late-stage’ failure of digital technologies in real-world settings is due to a lack of implementation science practice – this discipline is not given as much credit as it should be. Implementation science refers to the scalability of outcomes – with all the resources and training invested – observed in the clinical trial world and to the real clinical world. We may not be able to disseminate clinical trial outcomes and apply these in real-world settings. Learning about, sharing and employing implementation science, to the same degree as any other conventional science, is key.
Further, one must consider the alignment that occurs between patients, researchers and the technology. If you invent something that a hospital does not gain that much value form, the hospital may not invest a great deal of resources into advancing your technology. The same may be true for health plans and life science institutions – their level of resource input into advancement of novel technologies is likely dependent on the value they derive from the product.
Learning about, sharing and employing implementation science, to the same degree as any other conventional science, is key.”
Often, it is not the technology itself that creates reluctance to its adoption; rather, implementation science and value-creation alignment are the most common barriers to successful adoption of novel technologies and the translation of clinical trial success to real-world success.
In your opinion, why are some stakeholders reluctant to adopt digital transformations?
I certainly feel that there is this reluctance and I think one can define three main, contributing factors towards this. First, there is a significant lack of trust of the technologies on the part of health system organizations. These establishments question how ‘real’ the data is: is it evidence-based? Can the technology and data be of value to me? This trust will only be strengthened by real-world demonstrations of the benefits of digital transformations.
Second, there is a significant issue concerning the affordability of the inventions. Many new digital solutions are costly on two counts; the cost associated with the actual technology is only one area of concern. This initial, base cost is subsequently amplified three or four times by the costs of internal implementation and integration at institutions. Time and money must be invested into user training and data binding.
Thirdly, there is a lack of knowledge concerning how technologies can be used to generate success. What I mean by this is that companies may have observed how a technology or software has been successfully adopted at a startup company, however, they lack the knowledge to successfully recreate this and implement the software at their own companies. They may be driven to approach consulting firms to help with this, but the consultants’ fees further impact the affordability of the software for the company. Clearly, knowledge dissemination is required; this is something that I am very much involved in working on in association with the non-profit organization NODE.Health. This is now the largest professional organization in digital medicine and allows companies to gain, once they know they can afford a technology, affordable knowledge of how to implement it in practice.
What is the importance of patient engagement and feedback with respect to digital transformations in healthcare?
Patient feedback and input is very important; in our innovation lab at Mount Sinai, we partner with, and go on the journey alongside, patients. This is key to identifying patients’ real and important issues that need improvement and modification. Further, patient engagement allows us to determine whether what we are communicating to patients is being appropriately received by them. I think that having patients as true partners, not just in research, but also in digital medicine transformation, is one of the most effective – especially cost effective – measures that can be taken.
We seek to consider patients from all perspectives: problem identification, solution design, testing strategy, training and outcomes. Taking these considerations into account allow us to determine if the problems we are seeking to tackle are real for patients and if the solutions we are developing are relevant for patients. We can also gauge if we are testing our solutions in patients in the correct ways, training patients to utilize our solutions in the correct ways and if the resulting outcomes are as meaningful as they can be for patients.
What is your opinion on the incorporation of RWE into the assessment of precision therapies such as biologics?
I think this is something that is being done effectively, right now, with inflammatory bowel disease treatments – and a few other disease indications for which there are many biologic treatments on the market. The ultimate goal is for patients to have a standard set of novel digital technology tools at their disposal, through apps, allowing for quality improvement and best practices for future targets. However, within these apps, patients can also document their medicines and whether they are adhering to them correctly or suffering adverse side effects.
…RWE and digital medicine implementation will become mainstream practices bringing clinical practice and research together and that will have far greater impacts than we can even imagine now.”
Something we are working very actively on is that if we just try to engage patients in digital medicine for the sake of research and obtaining their information, we will not get long term patient engagement traction: you have to be providing something back to the patients so that they can know something beneficial for them is resulting from their engagement. By bringing the patient into clinical transformations and creating value for them, we can create new science and RWE/data. It therefore becomes a ‘no brainer’ for patients to continue engaging in the research process, as they can see the benefits that will be derived from their participation. Further, this drives the cost down.
How do you see the future of digital strategies in RWE and medicine evolving?
In the next 5 years, I think that we will see that the term ‘RWE’ will be synonymous with ‘evidence’ and ‘digital medicine’ will equate with ‘medicine’. We will stop distinguishing between these terms because RWE and digital medicine implementation will become mainstream practices that will have far greater impacts than we can even imagine now.