By Mark P. Wade, Executive Director, Life Sciences
Recently we attended the ISOQOL 25th Annual Conference in Dublin. As usual, it was well attended by professionals that live and breathe Clinical Outcome Assessment (COA) measures. Many of the sessions centered around meaningful change and interpreting those changes. While at times it felt like statistical gymnastics, the information was very relevant—especially as we can now receive data from many more devices (wearables) than just the subjective patient-reported instrument. But getting data for the sake of data might not be the best use of our time—employing certain statistical models as outlined in parts of the Stats Track will certainly help us monitor meaningful patient variance. Rather than swimming in deep data, we would divide the patient experience and correlate the subjective patient-reported outcome with the biometric data we are getting from the wearable devices.
Speaking of wearable devices, thanks to the plenary session on mobile health, we got an excellent overview of the FDA’s thinking about how this technology is moving forward. This includes new nomenclature—it will now be referred to as digital health, with digital health tools referring to the instrument we use to collect the data (handheld, wearable, etc.). While this may seem like a small change, it will change our verbiage, and may result in a need to update all of our published and non-published materials.