For quantified selfers, leveraging sensors and devices via apps to track health and wellness goals is now second nature. Elite athletes leverage these tools to push for peak performance. More recently, healthcare has started exploring how passive data collection can augment current models of care and create new ones. Imagine how useful having glucometer readings are to manage diabetes better? Or blood pressure readings that are automatically sent to a care team to better triage care. This is happening in many health systems today, but how much do we see this occur in clinical research? The importance of penetrating research means we have more reliable ways to translate how data from apps, sensors and devices can support the clinical management of chronic conditions. Indeed, in our current era of COVID-19, being able to talk to patients leveraging telehealth, and having current data is imperative for optimal management.
A new paper by Caroline Marra and colleagues from Harvard Business School in Boston in Nature Digital Medicine examines the degree to which digital products are showing up in clinical research. The authors developed six criteria to be considered a “digital product” (1) collection of health-related and clinical metrics (e.g., blood pressure), (2) inclusion of a software component, (3) inclusion of a sensor or device to connect to the software. A fourth criterion, being portable so a consumer could use it as part of their daily routines, (5) readily connecting to the internet via Bluetooth or mobile app and six, be designed for consumer use, thus not requiring medical interpretation of data.
The table below shows the products included and excluded from this review.
After mapping the criteria, the authors did a comprehensive search in ClinicalTrials.gov for models and products that met these six definitions. Findings indicate a 34% year-on-year growth in the use of digital products in clinical research starting in 2000. Moreover, 2017-2018 saw a tenfold increase in research compared to the early 2000s. Digital products are represented in all phases of research, also speaking to the depth and breadth of products researched, which may well be a proxy for the health of the field.
The advent of the iPhone in 2008 has been a game-changer for the use of digital products. Funding for research is also changing to a more blended model of industry and non-industry sources; this is important to ensure data use, transparency, and ethics are also built into clinical research.
The good news is the research community is holding a standard and also pivoting to develop robust methods to incorporate digital products into their research portfolios. If we are to move from “early adopter” to “early majority” utilization of digital health, we need more high-quality studies in a variety of populations to deploy these new tools in health care.
Thanks for reading – Trina
(Opinions are my own)
Marra, C., Chen, J.L., Coravos, A. et al. Quantifying the use of connected digital products in clinical research. npj Digit. Med. 3, 50 (2020). https://doi.org/10.1038/s41746-020-0259-x