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By: Joseph C. Kvedar, MD, Vice President of Connected Health, Partners HealthCare; Associate Professor of Dermatology, Harvard Medical School and Alexander L. Fogel, MBA, MD Candidate, Stanford University School of Medicine
Despite years of hype in the field of digital health products — a term that we use here to describe technologies that are designed to have clinical impact on disease — fewer products than expected are being deployed in real-world clinical settings. Many digital health products that demonstrate impressive results in clinical trials often fail to do so in real-world settings.
Why? Much of the success of digital health products is predicated on patient engagement, and clinical trials are among the most engaging environments in health care. Clinical trials involve the use of a variety of tools (e.g., training, close monitoring, payments) to ensure that patients use the technologies appropriately, but few of these tools are used in the real world. In order to cross the chasm from success in clinical trials to success in practice, digital health companies need to focus on patient engagement.
Engagement is so important because many digital health products are designed to achieve behavioral changes for the purpose of preventing or treating chronic diseases. For patients who are at risk for, or are living with, a chronic disease, successful prevention or management requires minute-to-minute, day-to-day changes in decision-making. Patients need to be highly motivated to make behavioral changes, they need to be praised when they follow through, and they need guidance when they slip up. The process needs to be sticky and self-reinforcing in order to maintain patient interest. In a nutshell, patients need to be engaged.
Engagement is important not only for clinical results, but also for the business models of many digital health companies, which frequently incorporate pay-for-performance contracts. Digital health companies need to track data continuously in order to demonstrate their value to the purchaser or user. Products that do not engage patients drag down performance metrics and reduce the viability of the company.
Contrast this with pharmaceuticals: payors pay for drugs before patients take them, and pay-for-performance contracts are the exception; this is part of the reason why nearly 50% of medications for chronic disease are not taken as prescribed.
Successful clinical trials of both digital health products and pharmaceuticals are engaging by definition. In order for a trial to demonstrate significant results — and in order for the results of the trial to be published — the attrition rate for participants needs to be very low. The entire endeavor is designed around ensuring that patients use the product or service appropriately and follow up regularly.
A clinical trial is designed as follows: an artificial scenario is crafted, willing participants volunteer, participants are carefully selected on the basis of optimal criteria, staffers are thoroughly trained, measurements are taken like clockwork, and participants are induced (by means of monetary payments or a barrage of phone calls, emails, and texts) to use the product or service as directed. As a result, the experience of individuals who are involved in a clinical trial typically is much more engaging than that of patients who use the technology in real-world scenarios.
Extending the engagement-boosting practices from a clinical trial to a much larger population of patients in the real world is not feasible because of cost and logistical complexity. As a result, different approaches are needed to facilitate engagement.
Clinical trials are a critical process in the evolution of digital health products. Evidence is an important means for convincing health care executives to buy these products. However, simply learning that an intervention was successful in a clinical study is not enough. Real-world validation is also important as digital health companies own the validation process from product development to scale. Once clinical validation is achieved, real-world evidence must be gathered to justify success at scale. In order for digital health products to make the leap from novelty to necessity, manufacturers will need to focus on driving patient engagement in real-world settings. Engagement will require taking lessons from other industries, creating products that are tailored to population subsets, developing synergistic partnerships, and understanding the performance characteristics of products in the real world.