CERSI Collaborators: Joseph Ross, MD, MHS (Yale) (PI), Nilay Shah, PhD (previously at Mayo Clinic, now at Delta Airlines) (PI), Joseph Akar, MD, PhD (Yale), Laura Ciaccio, MSc (previously at Yale, now at University of Dundee), Hayley Dykhoff (previously at Mayo Clinic, now at Health Services Advisory Group), Todd Kellogg, MD (Mayo Clinic), Peter Noseworthy, MD (Mayo Clinic), Kurt Roberts, MD (Yale)

FDA Collaborators: Fraser Bocell, PhD, Brittany Caldwell, PhD, Jun Dong, MD, Cynthia Long, MD, Anindita Saha

CERSI In-Kind Collaborators: AliveCor; University of California, San Francisco- Sanket Dhruva, MD, MHS

Non-Federal Entity Collaborators: Johnson and Johnson- Karla Childers, MSJ, Paul Coplan, ScD, MBA, Stephen Johnston, MSc

Project Start and End Date: August 2017-April 2020

Regulatory Science Challenge

Once medical devices are marketed, it is necessary and important to monitor their safety and effectiveness in real-world clinical practice. While the FDA currently uses multiple strategies for postmarket surveillance, there are opportunities for innovation. One novel approach to postmarket surveillance is to obtain health data from medical records, pharmacies, personal digital device data, and insurance claims, allowing for better insights into patients’ outcomes, as well as information on symptoms and experiences reported directly by patients. Integration of these multiple data sources has the potential to ultimately enable a more robust and thorough postmarket surveillance strategy by leveraging the potential of digital health technologies.

Project Description and Goals

A novel patient-centered health data sharing platform (digital health application) has been developed that enables patients to provide their own outcomes through short questionnaires and synchronizing data from mobile health trackers after a medical procedure. In addition, with user permission, this digital health application draws data from the patient’s electronic health record (EHR) to complement patient-reported data.

This study aimed to test the ability of this digital health application to enable the FDA to conduct postmarket surveillance of two procedures that use medical devices. Included in this study are sutures, surgical staplers, and other devices used to perform bariatric surgeries, which involve making changes to the digestive system in patients seeking weight loss. Also included in this study are ablation catheters, which are thin, flexible tubes that deliver heat or cold energy to create tiny scars in the heart to treat atrial fibrillation, the most common sustained abnormal heart rhythm.

Sixty patients who agreed to participate in this study at two US hospitals before receiving surgery for treating obesity (30 patients) or atrial fibrillation (30 patients) using each of the devices were asked to report specific symptoms at baseline and after the procedure. In addition, patients were provided Fitbit wearable devices to gather additional insights into their health and health outcomes. Finally, the feasibility of obtaining patients’ medication data from pharmacies was tested. (ClinicalTrials.gov Identifier: NCT03436082)

This study successfully obtained the following: 1) EHR data for all patients at both participating hospitals, as well as from ten additional health systems, 2) pharmacy data obtained for patients using CVS or Walgreens pharmacies, 3) personal digital device data from activity monitors (Fitbit), digital weight scales, and single-lead electrocardiograms, and 4) patient-reported outcome measure data obtained through surveys to assess post-procedure recovery and disease-specific symptoms.

Publications

Dhruva SS, Ross JS, Akar JG, Caldwell B, Childers K, Chow W, Ciaccio L, Coplan P, Dong Jun, Dykhoff HJ, Johnston S, Kellogg T, Long C, Noseworthy PA, Roberts K, Saha A, Yoo A, Shah N. Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform. NPJ Digit Med. 2020;3:60. DOI: 10.1038/s41746-020-0265-z