Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform

Joseph S. Ross,Stephen Johnston,Wing Chow,Laura Ciaccio,Joseph G. Akar,Nilay D. Shah,Peter A. Noseworthy,Sanket S. Dhruva,Cynthia Long,Todd Kellogg,Paul Coplan,Hayley J. Dykhoff,Karla Childers,Andrew Yoo,Anindita Saha,Jun Dong,Kurt Roberts,Brittany Caldwell

doi:10.1038/s41746-020-0265-z

Abstract

Real-world data sources, including electronic health records (EHRs) and personal digital device data, are increasingly available, but are often siloed and cannot be easily integrated for clinical, research, or regulatory purposes. We conducted a prospective cohort study of 60 patients undergoing bariatric surgery or catheter-based atrial fibrillation ablation at two U.S. tertiary care hospitals, testing the feasibility of using a patient-centered health-data-sharing platform to obtain and aggregate health data from multiple sources. We successfully obtained EHR data for all patients at both hospitals, as well as from ten additional health systems, which were successfully aggregated with pharmacy data obtained for patients using CVS or Walgreens pharmacies; personal digital device data from activity monitors, digital weight scales, and single-lead ECGs, and patient-reported outcome measure data obtained through surveys to assess post-procedure recovery and disease-specific symptoms. A patient-centered health-data-sharing platform successfully aggregated data from multiple sources.

Highlights

Medical products, including drugs and devices, play an important role in clinical medicine, can provide substantial benefits to patients, and are regulated by the Food and Drug Administration (FDA) in the United States
FDA increasingly moved towards a total product life cycle approach to medical product oversight, for medical devices, with increasing use of evidence derived from real-world data collected in the postmarket setting as part of efforts to further evaluate medical product safety and effectiveness[1,2]
Real-world data used for this purpose can be derived from multiple sources, such as administrative claims, electronic health records (EHRs), disease and device registries, data gathered through personal digital devices, and patient-generated health data, such as patient-reported function or symptoms[2,3,4]; aggregating data from multiple sources is often challenging

Summary

INTRODUCTION

Medical products, including drugs and devices, play an important role in clinical medicine, can provide substantial benefits to patients, and are regulated by the Food and Drug Administration (FDA) in the United States. To our knowledge, no study to date has aggregated multiple sources of patient health data, including personal digital device data, PROM data, EHR data, and data from pharmacies, devising an integrated approach that provides patients agency over their data while enabling pragmatic clinical research. We conducted a study to test the feasibility of surveys, 18 (35%) reported receiving care at an institution other using a patient-centered health-data-sharing platform, Hugo than YNHH or Mayo Clinic during the follow-up period; 6 (33%) of (Hugo Health; Guilford, CT), to aggregate multiple real-world data these 18 patients connected to outside EHR portals. We conducted an 8-week cohort study to assess the ability of the Hugo mHealth platform to aggregate multiple sources of real-world and healthcare system data for patients undergoing two procedures that use medical devices: bariatric surgery (sleeve gastrectomy and gastric bypass) and catheter-based atrial fibrillation ablation. These 14 encounters occurred at facilities or clinics within or affiliated with the health center, such that data representing these

RESULTS

DISCUSSION

Findings

METHODS