Can composite digital monitoring biomarkers come of age? A framework for utilization

Abstract

Introduction The application of digital monitoring biomarkers in health, wellness and disease management is reviewed. Harnessing the near limitless capacity of these approaches in the managed healthcare continuum will benefit from a systems-based architecture which presents data quality, quantity, and ease of capture within a decision making dashboard. Methods A framework was developed which stratifies key components and advances the concept of contextualized biomarkers. The framework codifies how direct, indirect, composite and contextualized composite data can drive innovation for the application of digital biomarkers in healthcare. Results The de novo framework implies consideration of physiological, behavioral and environmental factors in the context of biomarker capture and analysis. Application in disease and wellness is highlighted, and incorporation in clinical feedback loops and closed loop systems is illustrated. Conclusions The study of contextualized biomarkers has the potential to offer rich and insightful data for clinical decision making. Moreover, advancement of the field will benefit from innovation at the intersection of medicine, engineering and science. Technological developments in this dynamic field will thus fuel its logical evolution guided by inputs from patients, physicians, healthcare providers, end-payors, actuarists, medical device manufacturers, and drug companies.

Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)

“…Composite digital measures combine several individual measures, often derived from different sensors, to reach a single interpretive readout. For example, combining digital assessments of heart rate, sleep and heart rate variability can render a composite measure of depression 37 . Another example may combine accelerometer, GPS, keyboard and voice data from a smartphone to give a composite measure of cognition 38 .…”

SMART Markers: collecting patient-generated health data as a standardized property of health information technology

“…As smartphones continue to evolve and become secure personal health repositories, our framework demonstrates the capacity to facilitate such patient-led submission of PGHD from a variety of instruments, wearables, and digital devices through a familiar clinical construct. 33 In addition, SMART Markers can be adapted to enable novel use-cases with onsite or in-clinic kiosk setups initiating survey sessions for not only PROs but also to submit health data stored in growing list of web-based personal health repositories (e.g., Omron)-at the point of care, using FHIR.…”

The Need for Artificial Intelligence in Digital Therapeutics

“…Therefore, an invaluable attribute of digital therapeutics should involve precision medicine -the customization of healthcare with medical diagnosis, treatments, and practices tailored to individual patients [6]. Precision medicine through digital therapeutics can be provided through the utilization of digital biomarkers and clinical feedback loop systems, which could offer continuous physiological monitoring and dynamic responses to control healthy homeostasis [7,8]. Advanced artificial intelligence and machine learning systems can also incorporate hundreds of complex personal variables for each patient to provide more customized algorithms and interventions, which may be impossible for a human to evaluate.…”

“…For example, an insulin injection may provide a quick solution to control blood glucose levels for patients with diabetes, but it cannot continuously react to the body as an adaptable "artificial pancreas" providing interactive glycemic control and insulin delivery [9][10][11]. With an artificial pancreas, a patient wears a continuous glucose monitor using an electrochemical or optical sensor for glucose measurements in the interstitial fluid (i.e., a digital biomarker); an algorithm is then established to correlate to actual blood glucose levels and carbohydrate intake, and based on these measurements, precise insulin dosing is automatically delivered by a wearable insulin pump [7]. This allows the patient to stay in a more tightly controlled glycemic window without the potential detriments of prolonged periods of hyper-or hypoglycemia.…”

“…In conclusion, digital therapeutic systems have the potential to be a unique and efficient way to monitor symptoms, disease progression, and medication adherence, and provide relevant feedback interventions for patients and their clinical teams in various patient populations and disease states [7,8,12]. However, if digital therapeutics have a chance of being the "next best thing in healthcare," they need to offer something of significant value to patients and healthcare providers, besides simply encompassing digitized technology.…”