Get expert insights into cough science, monitoring and research
As new mechanism-based therapies emerge and the field continues to refine its endpoint strategies, objective, continuous cough monitoring represents a strategic quantitative approach to complement existing outcome measures in bronchiectasis.
“CDRH clearance is neither necessary nor sufficient for CDER to accept a cough monitor as a trial endpoint. The two run on independent tracks.”
FDA device marketing approval and clinical trial endpoint acceptability are different issues. Equating the two may confuse sponsors about risks involved.
Dr. Sophie Huddart is an Assistant Professor within the Department of Epidemiology and Biostatistics and the Institute for Global Health Sciences. She is interested in TB quality of care, especially how it influences the long-term outcomes of TB patients post-treatment. She also has expertise in digital health tools for monitoring of patient outcomes.
We were looking to test the new cough watches in our research context in Ugandan primary care centers. We wanted to know how the devices would fare without connection to a mobile network or phone for the duration of each observation period, which was three days.
We wanted a three-day snapshot of cough frequency at the time of TB treatment initiation, and then again 30 days later.
This pilot work was nested within the R2D2 TB Network, a multi-country research collaboration. We enrolled for this pilot in Uganda, with our colleagues at WALIMU. Other study members were at UCSF and UC Irvine.
We found the watches to be among the easiest of our digital health tools to get up and running. Hyfe was supportive throughout and provided high-quality training sessions and SOPs. We appreciated Hyfe's responsiveness in troubleshooting and updating the watch software. For example, our participants told us they'd like the watch to display the time so they didn't need to wear a second watch to tell the time, and Hyfe pushed that update within a week.
After resolving the time display, we had no complaints from our participants. They found the watches easy and unobtrusive to wear, and the data came back showing high adherence to requested wear time.
We used the dashboard to check data quality and wear time, to make sure participants were able to understand and adhere to the data collection procedures. Our team also used it to confirm successful data transfer. We found the dashboard easy to use and to access from all our sites.
After having used a variety of tools for research collection, what stood out was that the devices mostly just worked straight out of the box.
The watches are substantially more acceptable to participants. We have had a very low rate of refusal to participate in cough monitoring. The watches also required less staff support during data collection, because we were able to send them out on participants without requiring a study phone and charger during our short observation period. This has made it more feasible to use the watches with larger numbers of participants at once.
Objective, quantitative data is useful alongside our patient-reported outcomes to get a holistic sense of participant outcomes. The possibility of real-time syncing means we can design future research questions that use real-time decision-making to inform patient care.
