CureGN

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ABSTRACT Cure Glomerulonephropathy Research Network (CureGN) is an international multi-center National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-funded observational study of patients with minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, or Immunoglobulin A (IgA) nephropathy, with the goals to improve understanding of these conditions and outcomes for patients. Since 2014, CureGN has enrolled over 2600 patients at more than 60 clinical sites. A wide range of clinical data are collected to characterize disease course, treatment, and key outcomes at enrollment, three times yearly for the first 3 study years, and twice yearly thereafter. To collect these data, coordinators navigate the clinical record to locate information, enter it into the study's web-based data entry system (ArborLink), and respond to queries on a quarterly basis, oftentimes requiring re-opening of the clinical record. Given the near-universal adoption of electronic health records (EHR) and recent advances in health care information technology, opportunities to leverage EHR extraction for data collection present an important opportunity for CureGN to transition to a more modern chort study. Despite its potential, harmonization of EHR data across multiple institutions into curated research data sets has significant challenges. New mobile health technologies allow patients to share their data directly with researchers, seamlessly integrating EHR data from multiple health systems into a single data source. In addition, other study data collection activities such as survey and validated patient reported outcome administration can be assessed directly through the same application. This technology has been applied in large studies such as the NIH-funded All of Us and holds great potential for remote data collection in CureGN. This pilot study will (1) demonstrate the feasibility and scientific utility of EHR data sharing using the MyDataHelps mobile application and (2) identify priority targets for application functionality in both data collection and participant engagement in future CureGN studies. The pilot study will be implemented at four CureGN sites, one from each Participating Clinical Center (PCC). Standard data quality checks will be implemented and comparisons to manual data collection and entry into ArborLink will be made to assess reliability of EHR data collection through this method. Finally, the pilot study team will engage with stakeholders including site investigators, study coordinators, and research participants to assess how this type of mobile technology can be leveraged across the network in the future. The timing of the pilot study and preparation of a full consortium roll-out plan are critical to the successful continuation of CureGN.